Risultati per: Analisi RCT - quali sono i farmaci migliori per la lombalgia acuta?

Introduction
Autism is a lifelong neurodevelopmental condition diagnosed on the basis of differences in social communication, interaction and repetitive behaviours, including sensory sensitivities. Autistic individuals without intellectual disabilities often face barriers to positive adult outcomes and are at high risk for poor health, including mental health issues, which could be mitigated by improving well-being. Young people should receive support to increase their well-being during the transition to adulthood, when social and family support often reduces. This is the protocol for a feasibility randomised controlled trial (RCT) of an online peer-group intervention, ‘Understanding You, Discovering You’ (UYDY). Objectives included assessing recruitment and retention rates, acceptability of procedures, characterising usual care, assessing the acceptability of UYDY and care as usual (CAU) and calculating outcome measure variances for a full trial.

Methods and analysis
This two-arm parallel feasibility RCT includes a nested qualitative evaluation. Seventy participants aged 16–25 years old with a clinical autism diagnosis will be randomised on a 1:1 basis to UYDY or CAU. Exclusion criteria include risk of harm to self or others, receipt of postdiagnostic support in the past 12 months, and literacy levels such that the written session materials are not accessible. UYDY, a 6-week online peer-group intervention, will cover topics such as understanding autism, problem-solving and accessing services, and is facilitated by an autistic person and social care professionals. The main outcomes from the feasibility trial will be collecting data on (1) recruitment and retention rates; (2) the acceptability of randomisation and outcome measurement procedures; (3) CAU accessed by participants; (4) acceptability of the interventions; (5) clinical outcome measure variances (see below). See the Statistical methods section below for how this will be assessed in the current study. Clinical outcomes will be measured at baseline, and 8, 16 and 24 weeks post-randomisation. The primary clinical outcome is well-being, assessed using the Warwick Edinburgh Mental Wellbeing Scale. Secondary clinical outcomes include autism social identification, quality of life, social support and loneliness. Adverse events will be monitored and reported. Carer impact will also be measured. Participants will be recruited from England and Wales via charities and NHS services. Qualitative interviews will be conducted to explore the acceptability of trial participation including randomisation and the interventions.

Ethics and dissemination
Ethical approval has been obtained from the HRA and NHS REC (23/WA/0113). Informed consent will be collected from all participants (see online supplemental material for an example consent form). Results will inform the design of a full RCT and will be disseminated through peer-reviewed journals, conferences, and stakeholder events.

Trial registration number
ISRCTN10513626.

Introduction
Accumulating data support the association between increased inflammation and bipolar disorder (BD), and preliminary data suggest that augmentation with low-dose aspirin (LDA) may protect against the onset and deterioration of BD via anti-inflammatory pathways. The A-bipolar randomised controlled trial (RCT) aims to investigate whether adding LDA to standard treatment improves day-to-day mood instability (MI) in BD.

Methods and analysis
A two-arm, triple-blind, parallel-group, superiority RCT including 250 patients with newly diagnosed BD treated at the Copenhagen Affective Disorder Clinic, Denmark. Participants are randomised 1:1 to either 150 mg of acetylsalicylic acid daily (LDA) or a placebo for six months in addition to their regular treatment. Mood instability, calculated from daily smartphone-based mood evaluations, is the primary outcome measure due to its internal validity as a real-life measure for patients and external validity as it reflects patients’ illness severity and functioning. Analyses will be conducted as intention-to-treat analyses using a linear mixed model including time (categorical) and the time–treatment interaction as fixed effects and with an unstructured covariance pattern to account for repeated measurements on each study participant. The trial is Good Clinical Practice monitored.

Ethics and dissemination
The Danish Research Ethics Committee (H-21014515) and the data agency, Capital Region of Copenhagen (P-2021-576) approved the trial. Results will be published in peer-reviewed journals.

Trial registration number
NCT05035316.

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Riccardi: ‘Maggiore efficienza, sicurezza e tempi più rapidi’

Riccardi: ‘Maggiore efficienza, sicurezza e tempi più rapidi’

Introduction
School-age autistic children commonly experience social communication and interaction challenges in their everyday lives. While international evidence suggests that social skills group training (SSGT) programmes can support autistic children, improving their psychosocial functioning, to date there is no standardised evidence-based SSGT tailored towards the needs of autistic children aged 8–12 years living in the Chinese Mainland. Therefore, the primary objective of this study will be to evaluate the feasibility and acceptability of a culturally adapted 16-session version of the social skills programme KONTAKT in Chinese autistic children. Additionally, preliminary efficacy and cost-effectiveness will be assessed to inform a future definitive trial.

Methods and analysis
This study will employ a randomised, single-blinded, waitlist-controlled feasibility design with 36 Chinese autistic children aged 8–12 years with IQ over 70 referred to the Child Development and Behavior Center in Guangzhou, China. Participants will be randomly assigned to either the immediate training group or the delayed training group stratified by sex. Feasibility will be assessed using quantitative and qualitative data obtained from the KONTAKT CHILD participants, their parents and facilitators of the programme. Preliminary efficacy and cost-effectiveness are assessed via quantitative data obtained at five time points. The primary efficacy outcome is participants’ improvement in social skills as measured by the Contextual Assessment of Social Skills. Other outcomes include parents and teachers’ reports of participants’ autistic traits and adaptive functioning, participants’ self-report and projective tests for self-assertiveness and psychosocial functioning, and parent reports on parental reflective functioning and perceived school support. Common process factors and their effects on outcomes will also be explored. Cost-effectiveness will consider from both societal and healthcare perspectives.

Ethics and dissemination
The current study protocol has been reviewed and ethics approval has been obtained from the Ethical Board Committee at the Third Affiliated Hospital of Sun Yat-sen University (II2023-119-01). The trial was pre-registered in Chinese Clinical Trials (ChiCTR2300072136) on 5 June 2023. The results of this trial will be actively disseminated through peer-reviewed publications and conference presentations. Any identifiable personal information will be anonymised to protect confidentiality.

Protocol version
2.0, 31 July 2024.

Trial registration number
ChiCTR2300072136.

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